Received: 11.11.2025 Accepted: 24.11.2025 Published online: 29.12.2025
УДК 615.015.2:615.212:615.038
DOI: 10.53511/pharmkaz.2025.6.3
BIOEQUIVALENCE ASSESSMENT OF TWO LAMOTRIGINE
PREPARATIONS IN HEALTHY VOLUNTEERS
¹ Snaukshta V.S., ¹ Duisenova M.U., ¹ Tumabaevа А.М.,
² Veremeenko Т.N., ²Shaimardanova К.Y.
¹ Laboratory of pharmacological tests TB in Almaty State Enterprise with the Right of Economic
Management “National Center for Expertise of Medicines and Medical Devices”
Republic of Kazakhstan
² JSC «CHIMPHARM», Republic of Kazakhstan
Introduction: The bioequivalence of lamotrigine tablets from two manufacturers (100 mg dose) in
healthy volunteers was studied in a cross-sectional, open-label, randomized, two-sequence study. The concentration of lamotrigine in blood plasma samples was determined by HPLC with mass
spectrometric detection (LC-MS) for 72 hours. The main pharmacokinetic parameters were calculated for the studied drugs: AUC0-∞, AUC0-t, Cmax, Tmax. The 90% confidence interval of the AUC0-∞ ratio of the compared drugs was 0.98–1.02 and for Cmax – 0.97–0.99. In addition to the 90% confidence intervals, the two-way analysis of variance did not reveal statistically significant differences between the studied drugs. The conclusion is made about the bioequivalence of the compared lamotrigine preparations.
Materials and Methods: Lamotrigine concentrations were determined using a validated highperformance liquid chromatography (HPLC) assay. Based on pharmacokinetic analysis of lamotrigine concentration data at various time points (concentration-time curves), the following variables were determined: Primary variables: Cmax, AUC0-72 Secondary variables: tmax
Results: The 90% confidence interval calculated after analysis of the ln-transformed main
pharmacokinetic parameters Cmax and AUC0-72 of the comparator drug in relation to the reference drug was entirely within the range of 80.00–125.00%.
Discussions: thus, the study drug Lamotrigine-Santo, chewable tablets, 100 mg (JSC Khimfarm,
Republic of Kazakhstan), is bioequivalent to the reference drug Lamictal®, chewable tablets, 100 mg (GlaxoSmithKline Pharmaceuticals S.A., Poland).
Keywords: lamotrigine, bioequivalence, pharmacokinetics, LC-MS
PREPARATIONS IN HEALTHY VOLUNTEERS